Unique ID issued by UMIN | UMIN000042563 |
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Receipt number | R000048583 |
Scientific Title | Examination of the effectiveness of the lifestyle change program focusing on eating behavior by using FreeStyle Libre for employees suspected of having impaired glucose tolerance |
Date of disclosure of the study information | 2020/11/26 |
Last modified on | 2021/09/01 17:26:19 |
Examination of the effectiveness of the lifestyle change program focusing on eating behavior by using FreeStyle Libre for employees suspected of having impaired glucose tolerance
Examination of the effectiveness of the lifestyle change program focusing on eating behavior by using FreeStyle Libre for employees suspected of having impaired glucose tolerance
Examination of the effectiveness of the lifestyle change program focusing on eating behavior by using FreeStyle Libre for employees suspected of having impaired glucose tolerance
Examination of the effectiveness of the lifestyle change program focusing on eating behavior by using FreeStyle Libre for employees suspected of having impaired glucose tolerance
Japan |
Healthy Adults
Adult |
Others
NO
To verify the effectiveness of the lifestyle change program focusing on eating behavior by using FreeStyle Libre
Efficacy
Time In Range at 1W, 2W, 3W, and 4W.
The items below are evaluated at 1W, 2W, 3W, and 4W.
1)Standard deviation of blood glucose level
2)Percentage of time above Time In Range and percentage of time below Time In Range
3)Estimated HbA1c
4)Average blood glucose level
5)Number of low glucose events
6)Number of spikes
7)Number of scans by reader
The item below is evaluated at 1W, 4W, and 8W.
8)Behavioral change
The item below is evaluated at 1W and 4W.
9)BMI
The item below is evaluated by pictures.
10)Change of meal contents
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Device,equipment |
Measuring blood glucose level by freestyle libre at 1W, 2W, 3W, and 4W, provision of messages between 1W and 4W and doctor reports after 1W and 4W by app.
30 | years-old | <= |
64 | years-old | >= |
Male and Female
1)HbA1c was 5.6% -6.9% in the results of medical examinations for the last 2 years.
2)Diagnosed as hypertension and dyslipidemia but not diabetes
3)Consent was obtained from the subject participated in the preliminary briefing session of this study
4)Understand the purpose of research and use Libre properly
5)Daily use of smartphone
1)Diagnosed as diabetes
2)Having severe kidney disease, liver disease, heart disease, malignant tumor, etc.
3)May be pregnant or within 1 year after childbirth
4)Researchers judge that the participation in the research is inappropriate
5)Consent was obtained from the proxy
70
1st name | Jun |
Middle name | |
Last name | Fujita |
SOMPO Health Support Inc.
Information system Department
101-0063
Kanda Awaji-cho 1-2-3, Chiyoda-ku, Tokyo
0352098500
jfujita46@sompo-hs.co.jp
1st name | Hiromasa |
Middle name | |
Last name | Ida |
SOMPO Health Support Inc.
Business Planning & Development Department
101-0063
Kanda Awaji-cho 1-2-3, Chiyoda-ku, Tokyo
0352098523
hida89@sompo-hs.co.jp
SOMPO Health Support Inc.
Sompo Holdings, Inc,
Profit organization
Yamate Hifuka Clinic IRB
ST Shibuya Building, Dougenzaka 1-15-14, Shibuya-ku, Tokyo
0364169032
yamate@clinic-irb.com
NO
2020 | Year | 11 | Month | 26 | Day |
Unpublished due to the protocol including the intellectual property rights
Unpublished
Working in progress
50
Significant differences were found in the endpoints.
2020 | Year | 11 | Month | 26 | Day |
Healthy adults
50 participants completed and 50 subjects were incorporated into the analyses
Mild inflammation on the site where Libre sensor was attached to one subject was occurred.
Blood glucose level and behavior change
Completed
2019 | Year | 12 | Month | 23 | Day |
2020 | Year | 01 | Month | 15 | Day |
2020 | Year | 02 | Month | 06 | Day |
2020 | Year | 04 | Month | 01 | Day |
2020 | Year | 11 | Month | 26 | Day |
2021 | Year | 09 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048583
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